Gilotrif

PATIENT INFORMATION

GILOTRIF™
(JEE-loh-trif)
(afatinib) Tablets

Read this Patient Information before you start taking
GILOTRIF and each time you get a refill. There may be new information. This
information does not take the place of talking to your doctor about your
medical condition or treatment.

What is GILOTRIF?

GILOTRIF is a prescription medicine used to treat people
with non-small cell lung cancer (NSCLC),

that has certain types of abnormal epidermal growth
factor receptor (EGFR) genes, and

who have not had previous treatment for cancer that has
spread to other parts of the body

It is not known if GILOTRIF is safe and effective in
children.

What should I tell my doctor before taking GILOTRIF?

Before you take GILOTRIF, tell your doctor if you:

have kidney or liver problems

have lung or breathing problems other than lung cancer

have a history of severe dry eye or any other eye
problems. Tell your doctor if you wear contact lenses.

have heart problems

have any other medical conditions

are pregnant or plan to become pregnant. GILOTRIF can
harm your unborn baby. You should not become pregnant while taking GILOTRIF.

Women who are able to become pregnant should use
effective birth control during treatment with GILOTRIF and for at least 2 weeks
after your last dose of GILOTRIF. Talk to your doctor about birth control
methods that may be right for you.

Tell your doctor right away if you become pregnant while
taking GILOTRIF.

are breastfeeding or plan to breastfeed. It is not known
if GILOTRIF passes into your breast milk. You and your doctor should decide if
you will take GILOTRIF or breastfeed. You should not do both.

Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and herbal
supplements. GILOTRIF may affect the way other medicines work, and other
medicines may affect the way GILOTRIF works. Know the medicines you take. Keep
a list of them to show your doctor or pharmacist when you get a new medicine.

How should I take GILOTRIF?

Take GILOTRIF exactly as your doctor tells you to take
it.

Your doctor will tell you how many GILOTRIF tablets to
take and when to take them. Do not change your dose or stop GILOTRIF unless
your doctor tells you to.

Take GILOTRIF on an empty stomach at least 1 hour before
a meal or 2 hours after a meal.

If you miss a dose of GILOTRIF, take it as soon as you
remember. If it is within 12 hours of your next dose, skip the dose and just
take your next dose at your regular time.

Do not take 2 doses of GILOTRIF at the same time.

If you take too much GILOTRIF, call your doctor or go to
the nearest hospital emergency room right away.

What should I avoid while taking GILOTRIF?

Limit your time in the sun. GILOTRIF can make your skin
sensitive to the sun. You could get or have worsening rash or acne. You could
get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your
skin while you are taking GILOTRIF if you have to be in sunlight.

What are the possible side effects of GILOTRIF?

GILOTRIF may cause serious side effects, including:

diarrhea. Diarrhea is common with GILOTRIF and may
sometimes be severe. Severe diarrhea can cause loss of body fluid (dehydration)
and kidney problems that can sometimes lead to death. During your treatment
with GILOTRIF, your doctor should prescribe medicines to treat diarrhea. Take
this medicine exactly as your doctor tells you to. Tell your doctor if you have
diarrhea. Get medical attention right away if your diarrhea does not go away or
becomes severe.

skin reactions. GILOTRIF can cause redness, rash,
and acne. It is important to get treatment for skin reactions as soon as you
notice them. Take medicines to help skin reactions exactly as your doctor tells
you to. Get medical attention right away if you develop severe skin reactions
such as peeling or blistering of the skin.

lung or breathing problems. Tell your doctor right
away if you have any new or worsening lung problems, or any combination of the
following symptoms:

trouble breathing or shortness of breath

cough

fever

liver problems. Tell your doctor right away if you
have any symptoms of a liver problem which may include:

Tell your doctor if you have any side effect that bothers
you or that does not go away.

These are not all of the possible side effects of GILOTRIF.
For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.

How should I store GILOTRIF?

Store GILOTRIF at room temperature between 68°F to
77°F (20°C to 25°C).

Keep GILOTRIF in the original container and keep the
container tightly closed.

Keep GILOTRIF away from moisture and light.

Safely throw away (discard) any GILOTRIF that is out of
date or no longer needed.

Keep GILOTRIF and all medicines out of the reach of
children.

General information about GILOTRIF

Medicines are sometimes prescribed for purposes other
than those listed in a Patient Information leaflet. Do not use GILOTRIF for a
condition for which it was not prescribed. Do not give GILOTRIF to other
people, even if they have the same symptoms you have. It may harm them.

This Patient Information summarizes the most important
information about GILOTRIF. If you would like more information about GILOTRIF, talk
with your doctor. You can ask your doctor or pharmacist for information about
GILOTRIF that is written for health professionals.

For more information, go to www.gilotrif.com or call
Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY)
1-800-459-9906, or scan the code below to go to www.gilotrif.com.